Ignite Creation Date:
2024-05-06 @ 4:28 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT04999332
Status:
RECRUITING
Last Update Posted:
2023-11-15
First Post:
2021-07-08
Brief Title:
Perioperative Leucovorin Oxaliplatin Docetaxel and S-1 LOTS For Locally Advanced Gastric or Gastroesophageal Junction Cancer
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
A Phase II Trial of Perioperative Chemotherapy With Leucovorin Oxaliplatin Docetaxel and S-1 LOTS For Patients With Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOTS
Brief Summary:
The aim of the trial is to investigate the clinical efficacy and toxicity of perioperative chemotherapy with leucovorin oxaliplatin docetaxel and S-1 LOTS in patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who receive a curative surgery
Detailed Description:
The study is an open-label single-arm single-country and multi-center phase II investigator-initiated trial Patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who enroll the trial will receive perioperative chemotherapy with LOTS 14 days as a cycle 4 cycles every 2 weeks followed by operation and another 4 cycles every 2 weeks post-operatively The primary outcome is pathological response or curative resection rate The secondary outcome includes recurrence-free survival overall survival disease control rate protocol completion rate and adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None